What are the responsibilities and job description for the Quality Engineer position at ROMTech?
The Quality Engineer position reports directly to the Director of Quality. The Quality supports the execution of the design and development for new products and supports sustaining activities for existing legacy products.
Duties & Responsibilities:
- Design and review project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
- Work with the Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs.
- Audit, monitor, and witness test processes for compliance with requirements and keeping a watchful eye for risk opportunities.
- Ability to participate in gathering of QA Engineering metrics gathering and compiling for higher level review.
- Communicate regularly with Manufacturing and Test counterparts, and proactively engage in issue resolution
Other responsibilities as assigned
Minimum Experience: 5 years of experience in Medical Device Industry
- Strong knowledge of 21 CFR Part 820 (CGMP)
- Strong knowledge of quality management systems and manufacturing processes
- Strong experience with risk management (ISO 14971)
- Experience with Design Verification & Validation preferred
- Preferred: B.S. degree in Engineering, Math, Physical Science, or equivalent field
Formal GMP and CFR training strongly preferred
Language: Read, write, understand English
Computer: Microsoft Office (Word, Excel, PowerPoint, Project),
Math: High school level or higher
Physical: None
Other:
- Multi-tasking, prioritization
- Technical writing ability at a level sufficient to complete Design History File documentation (test protocols, test reports).
- Strong aptitude with spreadsheet utilization (pivot tables, data analysis and reporting)
- Problem-solving, assertiveness
- Ability to thrive in a fast-paced environment
Excellent interpersonal and communication skills